[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"muscle-invasive-bladder-cancer-mibc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:muscle-invasive-bladder-cancer-mibc":106},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,49,72,92,123,155,176,199,228,259,282,307],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100642575","phase-2-ev--toripalimab-vs-gc-as-neoadjuvant-therapy-in-locally-advancedhigh-risk-mibc-100642575",false,"NCT07647289","EV + Toripalimab vs GC as Neoadjuvant Therapy in Locally Advanced\u002FHigh-Risk MIBC","A Phase II, Two-arm, Open-label, Multicenter, Randomized Controlled Clinical Study Evaluating the Safety and Efficacy of Enfortumab Vedotin Combined With Toripalimab Versus Gemcitabine Combined With Cisplatin in the Neoadjuvant Treatment of Patients With Locally Advanced\u002FHigh-risk Muscle-invasive Bladder Cancer","Inclusion Criteria:\n\n* Voluntarily agree to participate in the study and sign the informed consent form (ICF).\n* Age ≥ 18 and ≤ 80 years at the time of signing the ICF.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Histologically confirmed muscle-invasive urothelial carcinoma of the bladder, with variant histology components comprising \\\u003C 50%.\n* Radiographically confirmed non-metastatic urothelial carcinoma (M0). Clinical stage must be locally advanced or possess high-risk features, including at least one of the following: clinical stage cT3-T4aNxM0, or definitive high-risk cT2 (e.g., accompanied by tumor-related hydronephrosis, lymphovascular invasion).\n* Participants must be evaluated as fit for and scheduled to undergo radical surgery, and clinically fit to tolerate cisplatin-based chemotherapy.\n* Able to provide tumor tissue samples (at least 5 unstained slides, or paraffin scrolls\u002Fblocks).\n* Expected life expectancy of at least 12 weeks.\n* Adequate organ function, defined by the following laboratory values (obtained without blood transfusion within 14 days or growth factor support within 7 days prior to testing): Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL; Platelet count (PLT) ≥ 100 × 10\\^9\u002FL; Hemoglobin (Hb) ≥ 90 g\u002FL; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × Upper Limit of Normal (ULN); Total bilirubin (TBIL) ≤ 1.5 × ULN; International Normalized Ratio (INR) ≤ 1.5 × ULN; Creatinine clearance ≥ 60 mL\u002Fmin (calculated using the Cockcroft-Gault formula); Left ventricular ejection fraction (LVEF) ≥ 50%; QTcF interval ≤ 480 ms.\n* Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of study treatment and must be willing to use highly effective contraception during the study and for 180 days after the last dose.\n* Male participants with female partners of childbearing potential must be surgically sterile or willing to use highly effective contraception during the study and for 180 days after the last dose.\n* Able to understand and comply with study visits, treatment plans, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n* Prior systemic anti-tumor therapy for urothelial carcinoma, including radiotherapy, chemotherapy, targeted therapy, or biological therapy (except for intravesical instillation therapy).\n* Prior treatment with PD-1\u002FPD-L1 inhibitors or antibody-drug conjugates (ADCs).\n* Active malignancies other than urothelial carcinoma within 3 years prior to the first dose, except for curatively treated malignancies (e.g., basal or squamous cell skin cancer, localized low-risk prostate cancer, papillary thyroid cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast).\n* Active autoimmune disease requiring systemic treatment (e.g., use of disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose; or received high-dose steroids (\\>10 mg\u002Fday prednisone equivalent) or other immunosuppressive medications within 14 days prior to the first dose. (Physiological replacement therapies are permitted).\n* Severe thromboembolic events or severe cardiovascular\u002Fcerebrovascular diseases within 1 year prior to the first dose, including but not limited to myocardial infarction, unstable angina, pulmonary embolism, cerebral hemorrhage, cerebral infarction, and deep vein thrombosis.\n* Major surgical procedure within 28 days prior to the first dose; or cystoscopy\u002Fureteroscopy biopsy or intravesical therapy within 7 days prior to the first dose.\n* Peripheral neuropathy ≥ Grade 2.\n* Severe dry eye syndrome, active keratitis, corneal ulcers, or conditions assessed by the investigator as increasing the risk of corneal disease and unsuitable for participation.\n* Active infections, including: Positive HBsAg with HBV-DNA copy number ≥ 500 IU\u002FmL; Positive HCV antibody with positive HCV-RNA; Positive HIV antibody; Active tuberculosis infection; Other active infections requiring systemic therapy within 7 days prior to the first dose.\n* Other severe or uncontrolled diseases, including but not limited to: Severe respiratory diseases (e.g., moderate-to-severe interstitial or obstructive pulmonary disease, severe asthma); New York Heart Association (NYHA) Class III or IV heart failure; HbA1c ≥ 8% (except for participants whose fasting blood glucose is stably controlled at ≤ 10 mmol\u002FL with medication); Poorly controlled hypertension (systolic BP ≥ 160 mmHg and\u002For diastolic BP ≥ 100 mmHg); Large pleural effusion or ascites requiring symptomatic treatment within 14 days prior to the first dose.\n* Receipt of live vaccines within 28 days prior to the first dose or plans to receive live vaccines during the study.\n* Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation.\n* Use of strong CYP3A4 inhibitors or inducers within 14 days prior to the first dose.\n* Known severe hypersensitivity or intolerance to the study drugs or any of their excipients.\n* Substance abuse or psychiatric disorders that may interfere with study compliance.\n* Any other condition that, in the opinion of the investigator, makes the participant unsuitable for the study.","ALL","18 Years","80 Years",{"count":20,"type":21},58,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this Phase II, open-label, multicenter, randomized controlled study is to evaluate the efficacy and safety of Enfortumab Vedotin in combination with Toripalimab compared to Gemcitabine plus Cisplatin. This regimen is evaluated as a neoadjuvant treatment for patients with locally advanced or high-risk muscle-invasive bladder cancer. Participants will be randomly assigned in a 1:1 ratio to one of two cohorts. Cohort A will receive Enfortumab Vedotin and Toripalimab for 3 treatment cycles. Cohort B will receive Gemcitabine and Cisplatin for 3 treatment cycles. Following the neoadjuvant treatment phase, patients will undergo radical cystectomy and pelvic lymph node dissection. The primary endpoint of the study is the 1-year Event-Free Survival (EFS) rate. Secondary endpoints include pathological downstaging rate (pDR), pathological complete response (pCR), Disease-Free Survival (DFS), Overall Survival (OS), and the assessment of adverse events. Additionally, the study will evaluate the relationship between treatment efficacy and the expression of PD-L1 and Nectin-4 in tumor tissues.",[27],"Muscle-Invasive Bladder Cancer (MIBC)",[29,30,31,32,33,34,35],"MIBC","Neoadjuvant Therapy","Enfortumab Vedotin","Toripalimab","Antibody-Drug Conjugates","Nectin-4","Urothelial Carcinoma","RECRUITING","2026-06-09",{"date":39,"type":40},"2026-06-15","ACTUAL",{"date":42,"type":40},"2025-04-15",{"date":44,"type":21},"2028-12",{"name":46,"class":47},"Peking University Third Hospital","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100642553","phase-2-multi-omics-based-phase--trial-of-trastuzumab-rezetecan-plus-camrelizumab-for-perioperative-therapy-in-her2-positive-muscle-invasive-urothelial-carcinoma-100642553","NCT07639983","Multi-Omics-Based Phase Ⅱ Trial of Trastuzumab Rezetecan Plus Camrelizumab for Perioperative Therapy in HER2-Positive Muscle-Invasive Urothelial Carcinoma","Phase Ⅱ Clinical Study on Predicting Perioperative Efficacy of Trastuzumab Rezetecan Combined With Camrelizumab in HER2-Positive Muscle-Invasive Urothelial Carcinoma Based on Multi-Omics","Inclusion Criteria:\n\n1. Aged ≥18 years old with no restriction on gender.\n2. Voluntarily participate in this trial, sign written informed consent form and have good treatment compliance.\n3. Histopathologically confirmed bladder urothelial carcinoma (carcinoma with squamous\u002Fglandular differentiation is acceptable only when urothelial component dominates the lesion).\n4. Clinically or radiologically diagnosed muscle-invasive bladder cancer (MIBC): cT2-T4a, N0-1, M0 per AJCC\u002FUICC staging system; all imaging assessments shall be completed within 28 days prior to enrollment.\n5. HER2-positive tumor defined as IHC 1+, 2+ or 3+ tested on archival tumor specimen before enrollment via designated or central laboratory.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n7. Candidates eligible for radical surgery: planned to receive radical cystectomy (RC), and investigators confirm feasibility of subsequent TURBT consistent with study protocol.\n8. Satisfactory major organ function to tolerate perioperative treatment:\n\n   * Hematology: ANC ≥1.5×10⁹\u002FL, PLT ≥100×10⁹\u002FL, Hb ≥90 g\u002FL;\n   * Liver function: ALT\u002FAST ≤2.5×ULN, total bilirubin ≤1.5×ULN;\n   * Renal function: creatinine clearance ≥50 mL\u002Fmin calculated by Cockcroft-Gault or MDRD formula;\n   * Cardiac function: LVEF ≥50% detected by echocardiography without symptomatic heart failure (due to trastuzumab-related cardiac risk).\n9. Fertile subjects agree to use effective contraception throughout study period and for defined duration after last study drug administration.\n\nExclusion Criteria:\n\n1. Patients with distant metastasis (M1), unresectable disease ineligible for radical surgery, or concomitant active malignancy requiring systematic anti-tumor therapy as assessed by investigator.\n2. Prior systemic anti-tumor therapy for current bladder cancer, including neoadjuvant\u002Fadjuvant\u002Fmetastatic chemotherapy, immunotherapy or anti-HER2 agents; previous exposure to PD-1\u002FPD-L1 inhibitors, anti-HER2 monoclonal antibodies or ADCs that may interfere with efficacy or safety evaluation per investigator's judgment.\n3. Previous pelvic radiotherapy, or unrecovered major surgery\u002Fsevere trauma within predefined time window before enrollment.\n4. Active autoimmune disease or patients requiring long-term systemic immunosuppressive therapy (daily prednisone\\>10 mg or equivalent dose; topical\u002Finhaled\u002Fshort-course steroid use is permitted).\n5. Uncontrolled active or severe bacterial infection, active tuberculosis; viral infection: HBsAg positive with elevated HBV DNA without standardized antiviral treatment, positive HCV RNA without disease control, or confirmed HIV infection per local institutional standard; clinically significant cardiovascular disorders including congestive heart failure, recent myocardial infarction, unstable angina, uncontrolled arrhythmia, baseline LVEF\\\u003C50%, or subjects inappropriate for trastuzumab administration judged by investigator.\n6. Previous or ongoing interstitial lung disease\u002Fnon-infectious pneumonitis, or obvious interstitial pulmonary changes on imaging with high risk of immune-related pneumonitis assessed by investigator.\n7. Known severe hypersensitivity to trastuzumab, camrelizumab or any excipients of investigational drugs; pregnant or breastfeeding females, or those planning pregnancy throughout study period.\n8. Severe psychiatric\u002Fcognitive disorder or substance abuse preventing regular follow-up and efficacy assessment.\n9. Any other conditions inappropriate for trial enrollment such as severe comorbidities or extremely short expected survival, as determined by the investigator.",{"count":57,"type":21},44,[24],"For patients with HER2-expressing muscle-invasive bladder cancer (MIBC), current neoadjuvant therapies dominated by platinum-based chemotherapy remain unsatisfactory with respect to improved clinical efficacy, pathological complete response (pCR) rates, and the achievement rate of tumor downstaging for bladder preservation; in addition, a subset of patients have limited tolerance or eligibility to chemotherapy. Therefore, this study aims to evaluate the neoadjuvant regimen of Ruikang Trastuzumab combined with Camrelizumab, to determine whether this regimen can, with acceptable safety profiles: elevate pCR rate and the proportion of patients downstaged to ≤T1 disease, enable bladder preservation based on TURBT for eligible patients, and explore predictive biomarkers to identify the population most likely to derive clinical benefits.",[27,61],"Urinary Bladder Cancer","NOT_YET_RECRUITING","2026-06-08",{"date":65,"type":40},"2026-06-10",{"date":67,"type":21},"2026-06-05",{"date":69,"type":21},"2028-12-31",{"name":71,"class":47},"Sheng Tai",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":4},"100637142","phase-2-trastuzumab-rezetecan-and-adebrelimab-as-neoadjuvant-therapy-for-her2-positive-muscle-invasive-bladder-cancer-100637142","NCT07624201","Trastuzumab Rezetecan and Adebrelimab as Neoadjuvant Therapy for HER2-Positive Muscle-Invasive Bladder Cancer","Neoadjuvant Trastuzumab Rezetecan and Adebrelimab for HER2-positive Muscle-invasive Bladder Cancer: a Phase II, Prospective, Single-arm, Multicenter Trial","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. ECOG performance status of 0 or 1.\n3. Histopathologically diagnosed muscle-invasive bladder cancer (MIBC) (cT2-T4a, N0-1, M0).\n4. Tumor tissue with HER2 expression (IHC 2+ or 3+) and suitable for radical cystectomy (RC) and transurethral resection of bladder tumor (TURBT).\n5. No prior systemic chemotherapy.\n6. At least one measurable lesion per RECIST v1.1 (spiral CT long diameter ≥10 mm or short diameter of enlarged lymph node ≥15 mm) before diagnostic surgery.\n7. Adequate organ function (no transfusion or hematopoietic growth factor within 2 weeks before blood count screening):\n\n   ANC ≥1.5×10⁹\u002FL\n\n   PLT ≥100×10⁹\u002FL\n\n   Hb ≥90 g\u002FL\n\n   TBIL ≤1.5×ULN (except subjects with Gilbert's syndrome)\n\n   ALT and AST ≤2.5×ULN\n\n   Cr ≤1.5×ULN\n\n   LVEF ≥50%\n\n   QTcF ≤450 ms\n8. Females of childbearing potential must agree to abstain from heterosexual intercourse or use reliable, effective contraception from signing informed consent until at least 120 days after the last dose of study drug; serum HCG must be negative within 7 days before starting study treatment; and must be non-lactating.\n9. A female is considered of childbearing potential if she has reached menarche, is not postmenopausal (≥12 consecutive months of amenorrhea without other cause), and has not undergone sterilization surgery (e.g., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).\n10. Male patients with partners of childbearing potential must agree to abstain from heterosexual intercourse or use reliable, effective contraception from signing informed consent until at least 120 days after the last dose of study drug. During the same period, male subjects must also agree not to donate sperm. Male subjects with pregnant partners must use a condom and no additional contraception is required.\n11. Subjects voluntarily join the study, sign written informed consent, and are expected to have good compliance with the study protocol.\n\nExclusion Criteria:\n\n1. Patients with any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, etc.); patients with vitiligo; patients with childhood asthma that has completely resolved and requires no intervention in adulthood may be included; patients with asthma requiring bronchodilators for medical intervention are excluded.\n2. Patients currently using immunosuppressants or systemic corticosteroids for immunosuppressive purposes (dose \\>10 mg\u002Fday prednisone or equivalent) and continuing use within 2 weeks before the first dose.\n3. History of severe allergic reactions to other monoclonal antibodies.\n4. Subjects with untreated central nervous system (CNS) metastases; subjects who have received prior systemic, radical treatment for brain or leptomeningeal metastases (radiotherapy or surgery) may be included if imaging confirms stability for at least 1 month, systemic corticosteroid therapy (dose \\>10 mg\u002Fday prednisone or equivalent) has been discontinued for more than 2 weeks, and they are asymptomatic.\n5. Hypertension that cannot be well controlled with antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).\n6. Poorly controlled cardiac clinical symptoms or diseases, including: 1) NYHA class ≥2 heart failure; 2) unstable angina; 3) myocardial infarction within 1 year; 4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 5) QTc \\>450 ms (male) or QTc \\>470 ms (female); 6) Left ventricular ejection fraction (LVEF) ≤50% (i.e., EF \\>50% is required for inclusion).\n7. Abnormal coagulation function (INR \\>2.0, PT \\>16 s), bleeding tendency, or currently receiving thrombolytic or anticoagulant therapy; prophylactic use of low-dose aspirin or low molecular weight heparin is permitted.\n8. Bleeding events of grade ≥2 per CTCAE v6.0 within 4 weeks before the first dose.\n9. Imaging shows tumor invasion into major blood vessels, or the investigator judges that the tumor has a very high possibility of invading major blood vessels during treatment, leading to fatal massive hemorrhage.\n10. Arterial\u002Fvenous thrombotic events within 6 months before the first dose, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.\n11. Patients who received prior chemotherapy (including platinum-based chemotherapy) or surgery less than 4 weeks before study drug administration; palliative radiotherapy less than 2 weeks before study drug administration; molecular targeted therapy (including other oral targeted drugs in clinical trials) within less than 5 half-lives before the first study drug dose, or prior treatment-related adverse events (excluding alopecia) not recovered to ≤CTCAE grade 1.\n12. Patients with radiation enteritis caused by pelvic radiotherapy within 12 months before study drug administration.\n13. Active infection, unexplained fever ≥38.5°C within 7 days before dosing, or baseline white blood cell count \\>15×10⁹\u002FL.\n14. Known history or evidence of interstitial lung disease or non-infectious pneumonitis that has required corticosteroid therapy; or patients who may interfere with the detection or management of suspected drug-related pulmonary toxicity.\n15. History of immunodeficiency, including positive HIV serology, or other acquired or congenital immunodeficiency diseases, or known active tuberculosis.\n16. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (HBV reference: HBsAg positive and HBV DNA ≥500 IU\u002Fml; HCV reference: HCV antibody positive and HCV viral load \\> upper limit of normal).\n17. Patients with another malignancy within the past 5 years or concurrently (excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; for patients with recurrent ovarian cancer with prior history of breast cancer, those with no recurrence for \\>3 years after radical breast cancer surgery are excluded).\n18. Prior treatment with anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies (or any other antibodies targeting T-cell co-stimulatory or checkpoint pathways).\n19. Receipt of live vaccine within 4 weeks before the first dose or possible receipt during the study period.\n20. Pregnant or breastfeeding female patients.\n21. Patients judged by the investigator to have other conditions that may affect the conduct of the clinical study, inability to comply with the protocol, or lack of cooperation, or patients at risk of study participation.",{"count":20,"type":21},[24],"This study aims to evaluate the efficacy and safety of neoadjuvant trastuzumab rezetecan combined with adebrelimab for the treatment of HER2-positive muscle-invasive bladder cancer.",[27],"2026-05-31",{"date":85,"type":40},"2026-06-03",{"date":87,"type":21},"2026-06-01",{"date":89,"type":21},"2029-06-01",{"name":91,"class":47},"Harbin Medical University",{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":101,"phases":4,"briefSummary":102,"conditions":103,"keywords":108,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":48},"100637474","comparison-of-ct-and-mr-vi-rads-imaging-for-local-bladder-cancer-staging-100637474","NCT07602010","Comparison of CT and MR (VI-RADS) Imaging for Local Bladder Cancer Staging","Prospective Diagnostic Accuracy Study Comparing CT and MRI (VI-RADS) for Local Staging of Newly Diagnosed Bladder Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Newly diagnosed bladder cancer on cystoscopy\n* Planned TURBT or cystectomy within 6 weeks\n* Eligible for both CT and MRI within 6 weeks\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Contraindications to MRI or iodinated contrast media\n* Prior treatment for bladder cancer\n* Pregnancy\n* Non-malignant bladder lesions\n* Tumors located in bladder diverticula",{"count":100,"type":21},150,"OBSERVATIONAL","This prospective diagnostic accuracy study compares computed tomography (CT) and multiparametric magnetic resonance imaging (MRI) using the Vesical Imaging-Reporting and Data System (VI-RADS) for local staging of newly diagnosed bladder cancer. All participants undergo both imaging modalities prior to transurethral resection of the bladder tumor (TURBT) or cystectomy. Histopathology serves as the reference standard.",[104,105,106,107],"Bladder Cancer","Urothelial Carcinoma (UC)","Muscle Invasive Bladder Cancer (MIBC)","Non Muscle Invasive Bladder Cancer",[109,110,111,112,113],"MRI","Computed Tomography","VI-RADS","Local Staging","Diagnostic Accuracy","2026-05-15",{"date":116,"type":40},"2026-05-22",{"date":118,"type":40},"2026-04-22",{"date":120,"type":21},"2028-10-31",{"name":122,"class":47},"Oslo University Hospital",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":101,"phases":4,"briefSummary":132,"conditions":133,"keywords":137,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":4},"100633665","tumor-budding-and-t1-substaging-in-urothelial-bladder-cancer-100633665","NCT07529639","Tumor Budding and T1 Substaging in Urothelial Bladder Cancer","Assessment of Tumor Budding and T1 Substaging as Histopathological Predictors of Outcome in Urothelial Bladder Carcinoma","Inclusion Criteria:\n\n* Patients with a urinary bladder mass, diagnosed by TUR biopsy as urothelial carcinoma.\n* Patients with full clinical data and complete medical reports.\n\nExclusion Criteria:\n\n* Cases with non-urothelial histological subtypes (e.g., pure squamous cell carcinoma).\n* Patients who received neoadjuvant chemotherapy or radiotherapy.\n* Cases with missing or inaccessible clinical follow-up data.\n* History of prior or concurrent malignancy.",{"count":131,"type":21},100,"Bladder cancer is a significant global and local health concern, and predicting how aggressive a patient's tumor will behave is critical for guiding treatment. This observational study aims to evaluate two specific microscopic features of urothelial bladder carcinoma to see if they can reliably predict patient outcomes: the depth of early tumor invasion (T1 substaging) and the presence of small clusters of cancer cells at the tumor's edge (Tumor Budding).\n\nResearchers will retrospectively analyze tissue samples (paraffin blocks) from at least 100 patients who were diagnosed with urothelial bladder carcinoma and underwent transurethral resection (TUR) at the South Egypt Cancer Institute between 2018 and 2024.\n\nThe tissue samples will be analyzed in two main ways:\n\n* Early-stage tumors (pT1 cases): Researchers will carefully measure the exact depth the tumor has invaded the bladder lining using anatomical and micrometric sub-classification systems.\n* More advanced tumors (pT2 cases): Researchers will examine the invasive edge of the tumors under a microscope to count \"tumor buds\" (single cells or small clusters of cells).\n\nBy comparing these detailed microscopic measurements with the patients' historical medical records, the study hopes to determine if T1 substaging and Tumor Budding are strong predictors of disease recurrence, disease progression, and overall patient survival.",[134,135,136,27],"Urothelial Bladder Carcinoma","Bladder Carcinoma","Non-Muscle-Invasive Bladder Cancer (NMIBC)",[138,139,140,141,142,143,144,145],"Tumor Budding","T1 Substaging","Histopathology","Disease Progression","Survival Outcomes","Transurethral Resection (TUR)","Epithelial-Mesenchymal Transition (EMT)","Invasion Depth","2026-04-08",{"date":148,"type":40},"2026-04-14",{"date":150,"type":21},"2026-05",{"date":152,"type":21},"2027-06",{"name":154,"class":47},"Assiut University",{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":22,"phases":164,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":48},"100629391","phase-2-probiotics-combined-with-targeted-therapy-plus-immunotherapy-in-bladder-preserving-setting-for-patients-with-mibc-100629391","NCT07474064","Probiotics Combined With Targeted Therapy Plus Immunotherapy in Bladder-Preserving Setting for Patients With MIBC","A Multicenter Randomized Controlled Study to Evaluate the Efficacy of Oral Probiotics Combined With PD-1 Monoclonal Antibody and Disitamab Vedotin in Bladder-Preserving Setting for Cisplatin-Ineligible Patients With Muscle-Invasive Bladder Cancer and Low Serum Butyrate","Inclusion Criteria:\n\n* Patients have histologically confirmed, radiologically staged cT2-3N0M0 urothelial carcinoma of the bladder, in which urothelial carcinoma is the predominant component (\\>50%).\n* Serum butyrate level \\\u003C46 μg\u002FL as determined by quantitative mass spectrometry.\n* HER2 expression is assessed by immunohistochemistry (IHC) on pretreatment tumor specimens, with confirmed IHC ≥1+.\n* Patients are deemed ineligible for radical cystectomy based on laboratory evaluation and patient preference.\n* Patients considered ineligible for cisplatin therapy and meeting at least one of the following criteria: ECOG performance status \\>1 or Karnofsky performance status of 60-70%; Creatinine clearance \\\u003C60 mL\u002Fmin; Hearing loss ≥ Grade 2 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0; Peripheral neuropathy ≥ Grade 2 (NCI-CTCAE v5.0); New York Heart Association (NYHA) Class III or higher heart failure.\n* ECOG performance status of 0-2.\n* Adequate cardiac, bone marrow, hepatic, renal, and coagulation functions.\n\nExclusion Criteria:\n\n* Prior ADCs or PD-1\u002FPD-L1 inhibitor therapy.\n* Known hypersensitivity to microbiota-related preparations (microecological products), RC48-ADC or Toripalimab or any of its components.\n* Receipt of other approved systemic anticancer therapy or systemic immunomodulatory agents (including but not limited to interferon, interleukin-2, and tumour necrosis factor) within 28 days prior to enrolment.\n* Prior radiotherapy for bladder cancer.\n* Prior antitumour drug therapy, except for the following: a. For patients who previously received systemic chemotherapy, a treatment-free interval of at least 3 months between the last dose and the start of induction therapy is required; b. Local intravesical chemotherapy or immunotherapy (including BCG) must be completed at least 1 week before initiation of study neoadjuvant treatment.\n* Surgery or significant trauma within 28 days prior to enrolment (implantation of vascular access devices and TURBT are not considered).\n* Severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to enrolment.\n* Receipt of live vaccines within 28 days prior to enrolment.\n* Active autoimmune disease requiring systemic treatment and considered by the investigator to potentially interfere with the study treatment.\n* Requirement for long-term high-dose corticosteroids or other immunosuppressive agents.\n* Clinically significant abnormalities that may affect treatment, including electrolyte disturbances, hypoalbuminaemia, interstitial lung disease, non-infectious pneumonitis, or other uncontrolled systemic diseases. These include uncontrolled diabetes, hypertension, or cardiovascular disease, such as active cardiac conditions within 6 months prior to enrolment.\n* Untreated chronic hepatitis B with HBV DNA ≥500 IU\u002FmL (2,500 copies\u002FmL) or known HBV carriers with active disease.\n* Active hepatitis C infection.\n* History of immunodeficiency, including positive human immunodeficiency virus (HIV) test, other acquired or congenital immunodeficiency disorders, or a history of allogeneic stem cell transplantation or solid organ transplantation.\n* Toxicities from prior therapies that have not recovered to baseline or stabilised.\n* Presence of other concomitant malignancies.",{"count":163,"type":21},146,[24],"The goal of this clinical trial is to learn if oral probiotics (Clostridium butyricum) work to improve the efficacy of targeted therapy plus immunotherapy in bladder preservation setting for cisplatin-ineligible T2-3N0M0 bladder cancer patients with low serum butyrate.\n\nThe main questions it aims to answer are: Do oral probiotics elevate serum butyrate levels and enhance the duation of bladder preservation interval with targeted therapy plus immunotherapy? Researchers will compare oral probiotics combined with targeted therapy plus immunotherapy to standard regimens (targeted therapy plus immunotherapy) to see if oral probiotics can improve its efficacy.\n\nParticipants will:\n\n1. Take oral probiotics and\u002For Disitamab Vedotin (HER2-ADC) and Toripalimab (PD-L1 inhibitor) for one year in total, which is divided into induction treatment period, intensive treatment period and maintenance treatment period.\n2. Return to the hospital for evaluation of tumor residual burden according to the follow-up plan, which will include urine cytology, imaging, surgical biopsy, and urine DNA methylation detection.",[106],"2026-03-15",{"date":169,"type":40},"2026-03-17",{"date":171,"type":21},"2026-03-26",{"date":173,"type":21},"2035-03-31",{"name":175,"class":47},"chenxu",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":184,"enrollmentInfo":185,"targetDuration":4,"studyType":22,"phases":187,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":5},"100615753","phase-2-neoadjuvant-zanidatamab--tislelizumab--chemotherapy-for-selective-bladder-preservation-in-her2-positive-mibc-100615753","NCT07296705","Neoadjuvant Zanidatamab + Tislelizumab + Chemotherapy for Selective Bladder Preservation in HER2-Positive MIBC","Selective Bladder Preservation After Neoadjuvant Zanidatamab Combined With Tislelizumab and Chemotherapy in Patients With HER2-Positive Muscle-Invasive Bladder Cancer: A Multicenter Study","HARBOR","Inclusion Criteria:\n\n1. Willing to participate, able to provide written informed consent, and able to understand and comply with study requirements and the assessment schedule.\n2. Age 18 to 85 years on the date of informed consent.\n3. Residual disease after TURBT; histologically confirmed urothelial carcinoma of the bladder staged cT2-T4aN0-1M0 per AJCC 8th edition by histology and imaging. For mixed histology, urothelial carcinoma must be predominant (≥50%).\n4. Availability of TURBT tumor tissue and corresponding pathology report; either fresh surgical tissue or unstained slides may be submitted.\n5. HER2-positive: IHC 2+ or 3+.\n6. No prior anti-HER2-directed therapy (including but not limited to HER2 antibodies, HER2-targeting ADCs, or HER2-targeted TKIs) and no prior PD-(L)1 therapy.\n7. ECOG performance status 0-2.\n8. Adequate organ function based on screening labs obtained ≤14 days before enrollment:\n\n   a. For the following counts, no growth-factor support within 14 days prior to sample collection: i. Absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL ii. Platelets ≥ 100 × 10\\^9\u002FL iii. Hemoglobin ≥ 90 g\u002FL b. INR or aPTT ≤ 1.5 × upper limit of normal (ULN) c. Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for Gilbert syndrome or isolated indirect hyperbilirubinemia) d. AST, ALT, and alkaline phosphatase ≤ 2.5 × ULN\n9. Women of childbearing potential must have a negative urine or serum pregnancy test within ≤7 days before enrollment and agree to use highly effective contraception during the study and for ≥120 days after the last dose of zanidatamab, tislelizumab, or chemotherapy (whichever occurs later).\n10. Non-sterilized men must agree to use highly effective contraception during the study and for ≥120 days after the last dose of zanidatamab, tislelizumab, or chemotherapy (whichever occurs later).\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women.\n2. Uncontrolled infection requiring systemic therapy.\n3. Diagnosis of another malignancy within the past 5 years.\n4. Major surgery or significant trauma within 28 days prior to enrollment (placement of a vascular access device and TURBT are not considered major surgery).\n5. Prior radiotherapy to the bladder for bladder cancer.\n6. Active autoimmune disease requiring systemic treatment that, in the investigator's judgment, would affect study therapy.\n7. Any of the following cardiovascular criteria:\n\n   1. Cardiac chest pain within ≤28 days before first study dose, defined as moderate pain that limits activities of daily living.\n   2. Symptomatic pulmonary embolism within ≤28 days before first study dose.\n   3. Any acute myocardial infarction within ≤6 months before first study dose.\n   4. Any history of heart failure of New York Heart Association (NYHA) Class III or IV within ≤6 months before first study dose.\n   5. Any ventricular arrhythmia of severity ≥ Grade 2 within ≤6 months before first study dose.\n   6. Any cerebrovascular accident within ≤6 months before first study dose.\n   7. Corrected QT interval (QTc by Fridericia): ≥470 msec for women or ≥450 msec for men.\n\n   i. Note: If the initial ECG shows QTc \\>450 msec (men) or \\>470 msec (women), a follow-up ECG should be performed to confirm.\n\n   h) Left ventricular ejection fraction (LVEF) ≤50% by multigated acquisition (MUGA) scan or echocardiography (ECHO). The same modality used at baseline must be used for follow-up assessments.\n8. History of acute myocardial infarction or ischemic stroke within 6 months.\n9. Human immunodeficiency virus (HIV) infection (i.e., positive antibodies to HIV-1\u002F2), active syphilis infection, or active tuberculosis infection.\n10. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n11. History of interstitial lung disease, non-infectious pneumonitis, or uncontrolled pulmonary disease, including pulmonary fibrosis or acute lung disease.\n12. Known hypersensitivity to any study drug.\n13. Concurrent participation in another clinical study, unless observational (non-interventional) or in the follow-up phase of an interventional study.\n14. Any other condition deemed by the investigator to render the patient ineligible.","85 Years",{"count":186,"type":21},25,[24],"This is a multicenter, open-label, prospective, single-arm, phase II study designed to evaluate the efficacy and safety of neoadjuvant zanidatamab combined with tislelizumab and chemotherapy, followed by selective bladder preservation, in patients with HER2-positive muscle-invasive bladder cancer (MIBC) staged cT2-4aN0-1M0.",[106],"2025-12-08",{"date":192,"type":40},"2025-12-22",{"date":194,"type":40},"2025-10-25",{"date":196,"type":21},"2029-12",{"name":198,"class":47},"Fujian Medical University Union Hospital",{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":22,"phases":208,"briefSummary":210,"conditions":211,"keywords":214,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":227},"100610255","home-intravenous-fluid-infusion-after-undergoing-radical-cystectomy-100610255","NCT07225205","Home Intravenous Fluid Infusion After Undergoing Radical Cystectomy","Home Intravenous Fluid Infusion After Undergoing Radical Cystectomy: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Adult patients greater than 18 years of age and older\n* Confirmed urothelial carcinoma on pathology, including muscle invasive, non-muscle invasive, and variant histology\n* Patient electing to undergo radical cystectomy with bilateral pelvic lymphadenectomy after counseling with a urologic oncologist.\n\nExclusion Criteria:\n\n* Patients undergoing radical cystectomy for benign indications (e.g. chronic bladder pain, fistulas, severe lower urinary tract symptoms)\n* Patients undergoing radical cystectomy for a non-bladder primary malignancy (e.g. rectal, colon, uterine cancers).\n* Patients with extensive locally advanced disease necessitating a pelvic exenteration\n* Contraindication to receiving home IVF therapy (i.e. pre-existing cardiac, renal, hepatic dysfunction)\n* Unwilling or unable to participate in 30 and 90 day follow-up phone calls.",{"count":207,"type":21},130,[209],"NA","Radical cystectomy is the standard of care for muscle invasive bladder cancer, however despite advances, it is still associated with high morbidity. Many complications may be driven by dehydration and it is unclear if a home intravenous fluid (IVF) infusion program post-operatively, which is an accepted standard practice, is beneficial. This study is a single institution randomized controlled trial where patients who choose to undergo radical cystectomy for bladder cancer will be randomized to an Enhanced Recovery After Surgery (ERAS) protocol with a home IVF program, consisting of 1 liter (L) of crystalloid fluid three times per week for four weeks, or ERAS protocol alone. The primary outcome will be 90-day hospital re-admissions, with secondary outcomes including 30 and 90 day complications.",[104,106,212,213],"Muscle Invasive Bladder Cancer Urothelial Carcinoma","Cystectomy",[213,104,106,215,216,217],"Fluids","IVF","ERAS","2025-11-19",{"date":220,"type":40},"2025-11-20",{"date":222,"type":40},"2025-11-01",{"date":224,"type":21},"2028-02-01",{"name":226,"class":47},"Johns Hopkins University",2,{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":22,"phases":237,"briefSummary":239,"conditions":240,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":258},"100493513","phase-1-a-study-to-assess-safety-tolerability-and-imaging-characteristics-of-68gaga-dpi-4452-and-to-assess-safety-tolerability-and-efficacy-of-177lulu-dpi-4452-in-participants-with-unresectable-locally-advanced-or-metastatic-solid-tumors-100493513","NCT05706129","A Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors","A Multicenter, Open-Label, Non-Randomized Phase 1\u002F2 Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Patients With Unresectable Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\nPart A, B, and C:\n\n* Written informed consent, dated and signed by the patient prior to any study-specific procedure.\n* Part B and C are not conducted in the United States of America.\n* Has histologically or cytologically confirmed, unresectable locally advanced or metastatic solid tumors of:\n* Clear cell renal cell cancer (ccRCC) - participants must have received at least one line containing Tyrosine kinase inhibitor (TKI) treatment and at least one line containing immune checkpoint inhibitor treatment in metastatic setting, meaning at least two lines of treatment in metastatic setting.\n* Pancreatic ductal adenocarcinoma (PDAC) - participants must have received at least one line of platinum- and\u002For gemcitabine-based regimen.\n* Colorectal cancer (CRC) - participants must have received at least one line of FOLFIRINOX or FOLFOX\u002FFOLFIRI in two lines in combination with anti-Vascular Endothelial Growth Factor (VEGF) or anti-Epidermal Growth Factor Receptor (EGFR).\n* Participants with CRC or PDAC: availability of fresh biopsy, OR an archival biopsy\u002Fsurgical specimen of the tumor (preferably, taken after last prior line of therapy).\n* For Part B and C only: Urothelial cancer (UC) patients must have received all available standard of care if eligible, including one line of platinum-based chemotherapy, enfortumab vedotin and pembrolizumab.\n* Presence of at least 1 non-irradiated tumor lesion detected at conventional imaging (computed tomography \u002F magnetic resonance imaging (CT\u002FMRI)) documented within 4 weeks prior to the \\[68Ga\\]Ga-DPI-4452 administration.\n* Measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.\n\nPart D:\n\nParticipants with imaging evidence of a single indeterminate renal mass (IDRM) of ≤ 7 cm in largest diameter (tumor stage cT1) on any conventional diagnostic imaging technique, suspicious for ccRCC and planned for total or partial nephrectomy, or interventional diagnostic (cystoscopy and retrograde pyelography or biopsy) within 90 days from planned \\[68Ga\\]Ga-DPI-4452 administration.\n\nPart E:\n\nRegardless of lines of treatment, participants with histologically or cytologically confirmed progressive, unresectable locally advanced or metastatic solid tumors of\n\n* UC, including MIBC\n* H\\&N cancer\n* TNBC\n* Squamous NSCLC\n* Any other indication with confirmed carbonic anhydrase IX (CA IX) expression excluding ccRCC, PDAC and CRC, upon Sponsor agreement.\n\nPresence of at least 1 non-irradiated tumor lesion detected at conventional imaging (CT\u002FMRI) documented within 4 weeks prior to the \\[68Ga\\]Ga-DPI-4452 administration (for scans dated more than 4 weeks prior to D1, the Sponsor should be contacted to assess conventional imaging suitability)\n\nExclusion Criteria:\n\n* Any major surgery within 12 weeks before enrolment.\n* Inability to stay in the scanner bed with the arms resting out of the thoracic and abdominal fields (i.e., arms alongside the body or raised arm position) for the duration of the scan.\n\nPart A:\n\n* Has known hypersensitivity to the active substance, to any of the excipients of the DPI-4452, or to radiographic contrast agents.\n* Bladder outflow obstruction or unmanageable urinary incontinence.\n* Participants who have not had resolution of clinically significant toxic effects of prior systemic cancer therapy, surgery, or radiotherapy to Grade ≤1 (except for laboratory parameters specified above, Grade 2 alopecia, and\u002For stable Grade 2 sensory neuropathy, according to National Cancer Institute Common Terminology Criteria for Adverse Events \\[NCI-CTCAE\\]).\n* Administration of a radiopharmaceutical within a period corresponding to 10 half-lives of the radionuclide used prior to injection of \\[68Ga\\]Ga-DPI-4452.\n* Previous Carbonic anhydrase (CA) IX-targeting treatment.\n* Prior external beam radiation therapy (EBRT) to more than 25% of the bone marrow, as judged by the Investigator.\n\nPart B and Part C:\n\n* Known hypersensitivity to the active substance, to any of the excipients of the DPI-4452, or to radiographic contrast agents.\n* Bladder outflow obstruction or unmanageable urinary incontinence.\n* Participants who have not had resolution of clinically significant toxic effects of prior systemic cancer therapy, surgery, active clinically significant cardiac disease, or radiotherapy to Grade ≤1 (except for laboratory parameters specified above, Grade 2 alopecia, or stable Grade 2 sensory neuropathy, according to NCI-CTCAE).\n* Administration of a radiopharmaceutical with therapeutic intent within a period of 6 months prior to injection of \\[68Ga\\]Ga-DPI-4452.\n* Any previous CA IX-targeting treatment for non-oncological indication within 3 months prior to the \\[177Lu\\]Lu-DPI-4452 infusion; any previous CA IX-targeting treatment for any oncological indication.\n* Participants who received any systemic antineoplastic therapy for the underlying disease and\u002For other investigational agents within a period which is ≤5 half-lives or ≤4 weeks (whichever is shorter).\n* Inflammatory bowel disease (e.g Crohn's disease, ulcerative colitis, etc).\n\nPart D:\n\n* Known hypersensitivity to the active substance, to any of the excipients of the DPI-4452, or to radiographic contrast agents.\n* Any previous CA IX-targeting treatment within 3 months prior to the \\[68Ga\\]Ga-DPI-4452 injection.\n* Administration of a radiopharmaceutical within a period corresponding to 10 half-lives of the radionuclide used prior to injection of \\[68Ga\\]Ga-DPI-4452.\n* Malignant disease, other than that being treated in this study. Exceptions include the following: malignancies that were treated curatively and have not recurred within 2 years prior to screening; treated basal cell or localized squamous skin carcinomas, localized or low grade (e.g., Gleason 3+3 or 3+4 with low prostate specific antigen) prostate cancer, superficial (non-muscle invasive) urothelial cancer, localized thyroid gland microcarcinoma, other in-situ carcinoma, or other malignancy for which participants are not on active antineoplastic therapy.\n* Ongoing treatment with sulfonamides and\u002For coumarin derivatives (e.g., acenocoumarol, warfarin, phenprocoumon) within 2 weeks (or 5 half-lives, whichever is longer) prior to the \\[68Ga\\]Ga-DPI-4452 injection.\n\nPart E:\n\n* Known hypersensitivity to the active substance, to any of the excipients of the DPI-4452, or to radiographic contrast agents.\n* Administration of a radiopharmaceutical within a period corresponding to 10 half-lives of the radionuclide used prior to injection of \\[68Ga\\]Ga-DPI-4452.\n* Any previous CA IX-targeting treatment within 3 months prior to \\[68Ga\\]Ga-DPI-4452 injection.\n* EBRT to more than 25% of the bone marrow, as judged by the Investigator.\n* Malignant disease, other than that being treated in this study. Exceptions include the following: malignancies that were treated curatively and have not recurred within 2 years prior to screening; treated basal cell or localized squamous skin carcinomas, localized or low grade (e.g., Gleason 3+3 or 3+4 with low prostate specific antigen) prostate cancer, superficial (non-muscle invasive) urothelial cancer, localized thyroid gland microcarcinoma, other in-situ carcinoma, or other malignancy for which participants are not on active antineoplastic therapy.\n\nNote: Other inclusion\u002Fexclusion criteria mentioned in the protocol may apply.",{"count":236,"type":21},270,[238,24],"PHASE1","The main purpose of Part A of the study is to evaluate safety, tolerability and tracer uptake after a single intravenous (IV) administration of \\[68Ga\\]Ga-DPI-4452 for each tumor type such as clear cell renal cell cancer (ccRCC), pancreatic ductal adenocarcinoma (PDAC), and colorectal cancer (CRC); Part B: is to determine the recommended phase 2 dose (RP2D) \\[maximum tolerated dose (MTD) or lower dose\\] for \\[177Lu\\]Lu-DPI-4452 for each tumor type such as ccRCC, PDAC, CRC, and urothelial carcinoma (UC); Part C: is to evaluate the preliminary antitumor activity of \\[177Lu\\]Lu-DPI-4452 as monotherapy for each tumor type such as ccRCC, PDAC, CRC, and UC; Part D: is to assess the diagnostic concordance between \\[68Ga\\]Ga-DPI-4452 Positron Emission Tomography (PET) and the histopathology result of the Indeterminate Renal Mass (IDRM); Part E: is to assess \\[68Ga\\]Ga-DPI-4452 uptake in each tumour type such as UC, muscle invasive bladder cancer (MIBC), head and neck cancer (H\\&N), triple negative breast cancer (TNBC), squamous non-small cell lung cancer (NSCLC), and any other tumor with locally confirmed carbonic anhydrase (CA) IX expression except ccRCC, CRC and PDAC.",[241,242,243,105,244,106,245,246,247],"Clear Cell Renal Cell Cancer (ccRCC)","Pancreatic Ductal Adenocarcinoma (PDAC)","Colorectal Cancer (CRC)","Indeterminate Renal Mass (IDRM)","Head and Neck Cancer (H&N)","Triple Negative Breast Cancer (TNBC)","Squamous Non-Small Cell Lung Cancer (NSCLC)","2025-10-16",{"date":250,"type":40},"2025-10-20",{"date":252,"type":40},"2023-03-14",{"date":254,"type":21},"2029-03",{"name":256,"class":257},"ITM Oncologics GmbH","INDUSTRY",10,{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":22,"phases":267,"briefSummary":268,"conditions":269,"keywords":270,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":4},"100608447","phase-2-vedisertib-rc48adc-combined-with-toripalimab-in-bladder-preserving-treatment-100608447","NCT07201675","Vedisertib (RC48\u002FADC) Combined With Toripalimab in Bladder-preserving Treatment","Inclusion Criteria:\n\n1. Voluntarily agree to participate in the study and sign the informed consent form;\n2. Male or female, age ≥ 18 years;\n3. Expected survival ≥ 18 months;\n4. Pathological and imaging diagnosis of cT2-4aN0M0MIBC;\n5. Subjects are able to provide specimens of tumor primary lesions detected by PD-L1 and HER2; HER2 IHC 1 or 2 or 3 ;\n6. No previous systemic therapy;\n7. ECOG performance status score of 0 or 1 point;\n8. Adequate cardiac, bone marrow, liver, and renal function (based on normal values at the study center):\n\n   1. Left ventricular ejection fraction ≥50%;\n   2. Hemoglobin ≥9 g\u002FdL;\n   3. Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL;\n   4. Platelets≥ 100 ×109\u002FL;\n   5. In patients without liver metastasis, serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN); Blood in liver metastases\n   6. Clear total bilirubin ≤3× ULN\n   7. ALT and AST ≤2.5 × ULN in the absence of liver metastases, ALT and AST≤5 × ULN in the presence of liver metastases;\n   8. Serum creatinine ≤1.5× ULN;\n9. For female subjects: should be zsurgically sterile, postmenopausal patients, or agree to use at least one medically approved contraceptive measure (such as intrauterine device \\[IUD\\], birth control pills, or condoms) during the study treatment period and for 6 months after the end of the study treatment period, must have a negative serum or urine pregnancy test within 7 days prior to study enrollment, and must be non-lactating. Male subjects should agree to use at least one medically approved contraceptive measure (such as condoms, abstinence, etc.) during the study treatment period and within 6 months after the end of the study treatment period;\n10. Willing and able to comply with trial and follow-up procedures.\n\nExclusion Criteria:\n\n1. History of malignant tumors other than urothelial carcinoma, except for the following two conditions:\n\n   1. Patients have received potentially curative therapy and no evidence of the disease within 5 years;\n   2. Successfully undergoing resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, and other carcinomas in situ;\n2. Suffering from diseases that affect the absorption, distribution, metabolism or clearance of the study drug (such as severe vomiting, chronic diarrhea, intestinal obstruction, malabsorption, etc.);\n3. Previous allogeneic stem cell or parenchymal organ transplantation; Patients who have received other anti-tumor systemic therapy (including traditional Chinese medicine with anti-tumor indications) in the past, less than 4 weeks after the completion of treatment to before the use of this study, or who have not recovered to ≤ CTCAE grade 1 (except for alopecia and pigmentation);\n4. Previous or current congenital or acquired immunodeficiency disease;\n5. Active or previous documented autoimmune or inflammatory diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, uveitis, hypophysitis, hyperthyroidism or hypothyroidism, asthma requiring bronchodilator treatment, etc.), vitiligo or asthma that has been completely resolved in childhood, and those who do not need any intervention in adulthood can be included;\n6. Use of systemic immunosuppressive drugs within 2 weeks prior to enrollment, or anticipation of need for systemic immunosuppressive drugs during the study, except for the following:\n\n   1. intranasal, inhaled, topical, or local injections (such as intra-articular injections) corticosteroids;\n   2. Systemic corticosteroids at doses not exceeding 10 mg\u002Fday of prednisone or other equivalent effects;\n   3. prophylactic use of corticosteroids for hypersensitivity;\n7. Patients have a known or suspected history of allergy to vidicitumab, anti-PD-1 drugs, or a history of hypersensitivity to chimeric or humanized antibodies or fusion proteins, or allergic to the excipients of the study drug;\n8. Thrombotic or thromboembolic events within the past 6 months, such as stroke and\u002For transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc.;\n9. Patients at risk of severe bleeding evaluated by doctors, including but not limited to severe bleeding (bleeding within 3 months\\> 30 ml), hemoptysis (bleeding within 4 weeks\\> 5 ml), if the above conditions occur, gastroscopy\u002Fevaluation can be performed, and the microscopic evaluation shall prevail; or have active bleeding or abnormal coagulation function, have a bleeding tendency or are receiving thrombolytic, anticoagulant or antiplatelet therapy;\n10. Significant clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe\u002Funstable angina or coronary artery bypass grafting within the past 6 months, congestive heart failure (NYHA classification\\> of the New York Heart Association Grade 2), poorly controlled or arrhythmias requiring pacemaker therapy, hypertension that cannot be controlled by medication (systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg);\n11. Other significant clinical and laboratory abnormalities that the investigator believes to affect the safety evaluation, such as: uncontrollable diabetes, chronic kidney disease, grade II or above peripheral neuropathy (CTCAE V5.0), abnormal thyroid function, etc.;\n12. Serious infection in the active phase or poorly controlled clinically; Active infection, including:\n\n    1. HIV (HIV) (HIV1\u002F2 antibody) positive;\n    2. Active hepatitis B (HBsAg positive or HBV DNA\\>2000IU\u002Fml with abnormal liver function);\n    3. Active hepatitis C (positive HCV antibody or HCV RNA ≥103 copies\u002Fml with abnormal liver function);\n    4. Active tuberculosis;\n    5. Other uncontrollable active infections (CTCAE V5.0 \\>2);\n13. Not yet recovered from surgery, such as unhealed incisions or serious postoperative complications;\n14. Pregnant or lactating women, as well as female or male patients of childbearing potential who are unwilling or unable to take effective contraceptive measures;\n15. Other conditions that the investigator deems unsuitable for inclusion.",{"count":266,"type":21},59,[24],"This is a phase II clinical study to evaluate the efficacy of RC48-ADC combined with toripalimab bladder-sparing therapy.\n\nThe RC48-ADC dose in this study is 2.0 mg\u002Fkg Q2W and toripalimab is 3 mg\u002Fkg Q2W.\n\nThis study plans to enroll 59 participants. The participants will start drug therapy within 2 weeks after the first diagnostic resection in the first stage, receiving RC48-ADC combined with toripalimab 3 times. At the 8th week after enrollment, the second stage of cystectomy was performed, and RC48-ADC combined with toripalimab was treated every two weeks thereafter for a total of 3 treatments. After the completion of the two-stage treatment, the participants should be discharged from the group by cystoscopy or other imaging examinations. On the contrary, if the participants have complete remission or partial remission, continue to the third stage of treatment, that is, receive RC48-ADC combined with toripalimab every two weeks for a total of 6 treatments, followed by cystoscopy, imaging, or a third cystectomy. If the participants achieve complete remission of the disease, maintenance immunotherapy will be given for 12 months. If the participants show that there is still a tumor, the participants will be discharged from the group for other treatments. Due to disease progression, death, participants voluntarily requested termination of study treatment, toxicity intolerance, initiation of new anti-tumor therapy, pregnancy, serious violation of the study process stipulated by the protocol, termination of study treatment determined by the investigator based on the best interests of the participants, loss to follow-up, whichever occurred first.\n\nDuring the study, the first and second electrotoxic tissues were sequenced using RNA and single-cell sequencing, and ctDNA was tested in urine before treatment, in the third month, and in the sixth month.",[106],[271,272,32],"RC48","muscle invasive bladder cancer","2025-09-30",{"date":275,"type":40},"2025-10-01",{"date":277,"type":21},"2025-12-01",{"date":279,"type":21},"2027-12-30",{"name":281,"class":47},"Qilu Hospital of Shandong University",{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":22,"phases":291,"briefSummary":292,"conditions":293,"keywords":294,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":303,"leadSponsor":305,"locationsCount":4},"100595008","mri-guided-bladder-preservation-program-for-patients-with-muscle-invasive-bladder-cancer-100595008","NCT07026864","MRI-Guided Bladder Preservation Program For Patients With Muscle Invasive Bladder Cancer","Project #1: MRI-guided Bladder Cancer Preservation Program","Inclusion Criteria:\n\n1. Patients with T2-T3N0M0 unifocal bladder cancer of any histologic subtype except squamous cell carcinoma or adenocarcinoma (Janopaul-Naylor et al., 2021) treated the maximal TURBT and able to tolerate concurrent chemoradiotherapy. Selected patients with high risk of common iliac involvement (T4 disease and\u002For limited N+ disease and\u002For LVSI+ status) able to receive the following treatment may be included as well. Additional criteria include:\n2. Karnofsky performance status \\> 70 with medical condition not contraindicating treatment with radical intent including maximal TURBT and concomitant chemotherapy;\n3. WBC equal or greater than 3500 mm3; platelet count equal or greater than 135000 mm3; hemoglobin equal or greater than 10 gr\u002FL; BUN equal or less than 20; serum creatinine equal or less than 2.0.\n\nExclusion Criteria:\n\n1. Prior radiation therapy to the target areas;\n2. Inability to undergo a MRI exam",{"count":290,"type":21},31,[209],"The goal of this clinical trial is to learn if the use of MRI-guided irradiation increases the rates of bladder preservation as well as to decrease complications in patients with muscle invasive bladder cancer who wish to retain their bladders",[106],[295,296,297,298],"Muscle Invasive Bladder Cancer","Bladder Preservation","Radiation Therapy","MR-Guided Radiation Therapy","2025-08-22",{"date":301,"type":40},"2025-08-24",{"date":275,"type":21},{"date":304,"type":21},"2030-07-01",{"name":306,"class":47},"Clinica Universidad de Navarra, Universidad de Navarra",{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":22,"phases":316,"briefSummary":318,"conditions":319,"keywords":323,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":48},"100598150","phase-3-treatment-expedition-with-mri-processing-and-optimization-for-muscle-invasive-bladder-cancer-100598150","NCT07067749","Treatment Expedition With MRI Processing and Optimization for Muscle Invasive Bladder Cancer","TEMPO-MIBC","Inclusion Criteria:\n\n* Clinical suspicion of muscle invasive bladder cancer at cystoscopy and pre-cystoscopy imaging\n\nExclusion Criteria:\n\n* Anticipated survival \\\u003C 3 months due to comorbidities\n* Pregnant patients\n* Breastfeeding patients\n* Previous chemotherapy within 6 weeks\n* Previous radiotherapy withing 6 weeks\n* Previous TURBt within 6 weeks\n* Severe renal impairment (eGFR \\\u003C 40 mL\u002Fmin\u002F1.73 m2)\n* non MRI-compatible metal implants\n* Claustrophobia\n* Denial of written consent to participate in the study",{"count":315,"type":21},92,[317],"PHASE3","The TEMPO-MIBC trial is a phase III, single-center, two-arm, randomized, controlled trial. Its primary objective is to evaluate the efficacy of a simplified diagnostic and treatment pathway for muscle-invasive bladder cancer (MIBC). This study investigates the role of multiparametric bladder MRI (mpMRI) in patients with biopsy proven cancer of the bladder with clinical features of detrusor muscle invasion. In the experimental arm, enrolled patients will receive a bladder mpMRI, if this exam will confirm the high suspicion of muscle invasion a conventional endoscopic transurethral resection of bladder tumour (TURBt) for staging purposes will be foregone and patients will immediately access the next step of their clinical management. Experimental arm outcomes will be compared to a control arm in which all enrolled patients will be receiving TURBt as part of the standard management of bladder cancer. The aim of this study is demonstrating a significant reduction of the time needed to offer patients the definitive treatment for their disease, possibly ensuring better long-term oncological outcomes.\n\nA blood sample will be collected from each patient enrolled in the study at pre-planned time points to measure the levels of circulating tumour (ctDNA), a primer will be built from bladder cancer biopsies performed at enrolment. ctDNA has been shown to be a proxy measure of tumour burden and residual molecular disease after treatment. The ctDNA levels in the experimental arm will be compared to those of the control arm to investigate wether foregoing endoscopic resection of the tumour and reducing time to definitive cancer treatment might be associated to lower ctDNA levels.",[320,321,135,322,106],"Bladder (Urothelial, Transitional Cell) Cancer","Bladder Cancer Requiring Cystectomy","Bladder Neoplasm",[295,111,324,213,325,326,327,328],"Bladder Magnetic Resonance Imaging","TURBT","treatment expedition","cancer management optimisation","circulating tumour DNA","2025-07-19",{"date":331,"type":40},"2025-07-24",{"date":333,"type":21},"2025-08-15",{"date":335,"type":21},"2030-08-15",{"name":337,"class":47},"University of Rome Tor Vergata"]